Events

Recall of Easyvision Umere Daily Contact Lenses (-6.50)30 x lenses for daily wear

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Specsavers Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00303-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00303-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    It has come to the attention of specsavers that a batch of 74 boxes of 30 easyvision 'umere' daily contact lenses have been incorrectly labelled as -6.50 prescription lenses when in fact they were - 4.50 lenses. affected lenses were supplied only to specsavers' online customers between 1 october 2014 and 20 february 2015.
  • Action
    Customers will be asked to identify whether they hold an affected box of contact lenses and the customer will be requested to return these in a post paid Toll bag provided by Specsavers. Specsavers will be sending replacement stock to all customers. For further information, please see https://www.tga.gov.au/alert/specsavers-easyvision-umere-daily-contact-lenses.

Device

Easyvision Umere Daily Contact Lenses (-6.50)30 x lenses for daily wear
  • Model / Serial
    Easyvision Umere Daily Contact Lenses (-6.50)30 x lenses for daily wearLot number R0031987 ARTG number: 186961
  • Manufacturer
    Specsavers Pty Ltd

Manufacturer

Specsavers Pty Ltd